Last updated on April 2019

A Safety Study of SGN-2FF for Patients With Advanced Solid Tumors

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Colorectal Cancer | head and neck cancer | Squamous Cell of Head and Neck | bladder cancer | Renal Cell Carcinoma | Gastroesophageal Junction Adenocarcinoma | Non-Small Cell Lung Cancer | Carcinoma | Breast Cancer | Gastric Adenocarcinoma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Patients with histologically or cytologically-confirmed, locally advanced, or metastatic solid malignancy that is relapsed, refractory, or progressing following at least 1 prior systemic therapy (Part A)
  • Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1
  • Patients in Part B must have histologically or cytologically-confirmed, locally-advanced, or metastatic solid malignancy within the disease indications of Part A
  • Adequate baseline hematologic, renal, and hepatic function
  • Patients for whom there is no further standard therapy available at the time of enrollment (Part A)
  • Patients with a histologically-confirmed, advanced solid malignancy meeting one of the following criteria: (1) indication for which pembrolizumab is approved or (2) relapsed, refractory, or progressive disease following at least 1 prior therapy and for which no further standard therapy is a available (Parts C and D)

Exclusion Criteria:

  • Patients with carcinomatous meningitis or active central nervous system (CNS) metastases
  • Patients with recent (within 14 days) or serious ongoing infection
  • Patients requiring systemic treatment with corticosteroids (greater than 10 mg prednisone equivalents) or immunosuppressive medications within 14 days of enrollment
  • Patients with active known or suspected autoimmune disease or significant autoimmune-related toxicity from prior immuno-oncology therapy
  • Known active or latent tuberculosis
  • Uncontrolled diabetes mellitus
  • History of interstitial lung disease
  • Gastrointestinal abnormality that would affect absorption of SGN-2FF
  • Patients tested positive for hepatitis B or with a known, active hepatitis C infection
  • Women who are pregnant or breastfeeding
  • Patients with deep vein thrombosis (DVT)
  • Contraindication to prophylactic anticoagulation

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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